Retrospective Clinical Validation of HepatoPredict

NCT06894524 | Not Yet Recruiting

• 1 other identifier: 326619
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

HepatoPredict is an innovative prognostic tool to support hepatologists, hepatobiliary surgeons and multidisciplinary teams in deciding on the best therapeutical approach for a patient with Hepatocellular Carcinoma, the most common type of primary liver cancer. HepatoPredict is a laboratory test that analyses a molecular signature from a small tumour sample and combines this information with details from imaging tests, such as the number of nodules and their size. Using a computational model, HepatoPredict determines whether a patient is likely to remain disease-free after hepatic surgery (good prognosis) or if there is a higher chance of the tumour returning (bad prognosis). Current selection criteria to assess the eligibility of patients with Hepatocellular Carcinoma for liver transplantation present several problems, including:

1. 1.selection of patients that will not benefit from a transplant. This could be due to recurrence of cancer or early death from another cause.
2. 2.exclusion of patients who could benefit from a liver transplant but are currently not eligible;
3. 3.increased tumor recurrence rates. Thus, improved tools that predict the likelihood of cancer coming back are needed to better assess if a patient will benefit from hepatic surgery. This will allow better use of organs, waiting list times, and improve ways of identifying the most appropriate treatments for individual patients.

Conditions

Hepato Cellular Carcinoma (HCC); Liver Resection; Liver Transplantation

Keywords

HepatoPredict; Liver Transplant; Liver Resection; Prognosis; Hepatocellular Carcinoma (HCC); HCC Recurrence

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Survival (RFS)

  This study aims to retrospectively evaluate the predictive power of HepatoPredict (positive and negative) to prognosticate patient's outcome and recurrence, after surgical treatment of Hepatocellular carcinoma (liver transplantation or liver resection). To this aim two outcome measure will be used: recurrence free survival (RFS) and overall survival (OS).

  Prior to 2019, until the begining of the study

Secondary Outcomes (1)

• Overall Survival (OS)

  Prior to 2019, until the begining of the study

Study Arms (2)

Patients with HCC, who underwent liver transplantation

Patients with early to intermediate HCC that underwent liver transplantation, with at least 5-year clinical follow-up.

Patients with HCC, who underwent liver resection

Patients with early to intermediate HCC that underwent liver resection, with at least 5-year clinical follow-up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with early to intermediate HCC that underwent liver transplantation or liver resection, with at least 5-year clinical follow-up, that have FFPE surgical fragments/explants still available.

You may qualify if:

• Age ≥ 18 years old.
• Patients with HCC that underwent transplantation, with at least 5 years follow-up.
• Patients with HCC that underwent surgical resection, with at least 5 years follow-up.
• Completed informed consent process (for patient candidates that are still alive).

You may not qualify if:

• Age \< 18 years old.
• Other non-HCC liver cancers patients.
• Patients with tumor extra-hepatic spread at diagnosis.

Sponsors & Collaborators

• Ophiomics: lead
• University Hospital Birmingham NHS Foundation Trust: collaborator

Related Publications (3)

• Andrade R, Perez-Rojas J, da Silva SG, Miskinyte M, Quaresma MC, Frazao LP, Peixoto C, Cubells A, Montalva EM, Figueiredo A, Cipriano A, Goncalves-Reis M, Proenca D, Folgado A, Pereira-Leal JB, Oliveira RC, Pinto-Marques H, Tralhao JG, Berenguer M, Cardoso J. HepatoPredict Accurately Selects Hepatocellular Carcinoma Patients for Liver Transplantation Regardless of Tumor Heterogeneity. Cancers (Basel). 2025 Feb 2;17(3):500. doi: 10.3390/cancers17030500.

  PMID: 39941867 BACKGROUND

• Goncalves-Reis M, Proenca D, Frazao LP, Neto JL, Silva S, Pinto-Marques H, Pereira-Leal JB, Cardoso J. Analytical validation and algorithm improvement of HepatoPredict kit to assess hepatocellular carcinoma prognosis before a liver transplantation. Pract Lab Med. 2024 Feb 5;39:e00365. doi: 10.1016/j.plabm.2024.e00365. eCollection 2024 Mar.

  PMID: 38371895 BACKGROUND

• Pinto-Marques H, Cardoso J, Silva S, Neto JL, Goncalves-Reis M, Proenca D, Mesquita M, Manso A, Carapeta S, Sobral M, Figueiredo A, Rodrigues C, Milheiro A, Carvalho A, Perdigoto R, Barroso E, Pereira-Leal JB. A Gene Expression Signature to Select Hepatocellular Carcinoma Patients for Liver Transplantation. Ann Surg. 2022 Nov 1;276(5):868-874. doi: 10.1097/SLA.0000000000005637. Epub 2022 Aug 1.

  PMID: 35916378 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: March 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03